Biotech experts urge industry to work with researchers or risk federal action

WASHINGTON, DC—(14 October 2008) – The intellectual property (IP) system in the United States is broken and must be transformed if it is to foster biotechnological advances and ensure that treatments and cures for diseases reach patients, national and international IP and biotech leaders said today.

At a briefing on Capitol Hill, McGill University’s Richard Gold, SJD, and Duke University’s Robert Cook-Deegan, MD, revealed the results of a case study that documents for the first time mistakes made by a US company in protecting and enforcing patent rights on breast cancer genes in the United States and abroad. And contrary to what industry has argued, they said, Myriad Genetics’ “hardball” tactics are the norm in the biotech and pharmaceutical industry.

“Our findings suggest that patent holders are not doing a good job of sharing information and biotechnological tools to foster innovation and access to vital genetic data,” said Cook-Deegan, “and government must be prepared to intervene when they do not.”

The conclusions presented by Gold and Cook-Deegan today are echoed in a new groundbreaking report – Toward a New Era of Intellectual Property: From Confrontation to Negotiation – from the International Expert Group on Biotechnology, Innovation and Intellectual Property, chaired by Gold, and in a series of new case studies prepared by the Expert Group and by Duke University, chronicling the development and commercialization of several genetic diagnostic tests.

The authors of the report say that the pharmaceutical and biotechnology industries’ heavy reliance on patents and aggressive enforcement of IP—the era of “Old IP”—are creating an environment of intimidation that prevents scientists from using tools that are vital to innovation, while blocking access to diagnostic tests that may have important implications for science and for public health.

Based on consultations with more than 100 researchers and other representatives of industry, government, academic research centers and non-governmental organizations, and more than 10 years of data from 17 countries, the Montreal-based International Expert Group found “there is universal acknowledgment that the biopharmaceutical innovation system is broken,” Gold said.

“As a result, the biopharmaceutical industry has fewer and fewer products in their pipelines,” he added, “and more and more of those products are ‘me-too’ drugs, which target diseases for which treatments have already been developed.”

According to Gold and Cook-Deegan, if patent holders don’t change their behavior and government agencies don’t act, pressure will grow on legislators to intervene.

“The solution in the United States is not to prevent patenting activity, but for government to make clear it will step in and exercise rights it has already,” said Cook-Deegan, director of the Center for Genome Ethics, Law & Policy at the Duke Institute for Genome Sciences & Policy. He notes that under the 1980 Bayh-Dole Act, universities, small businesses and non-profits are allowed to control their inventions and other IP that results from federal funding. But the government retains the right to “march-in,” or intervene on behalf of the public and grant additional licenses, if it sees the need.

“The fact is, in the 28 years since the Bayh-Dole Act was enacted, the government has never asserted its right to ‘march-in,’ whether for health or safety reasons, or to push for action to achieve practical application of a given invention,” said Cook-Deegan. “And industry knows that.”

When Aggressive Tactics Backfire

Cook-Deegan and Gold point to the case studies discussed in Washington today as illustrations of the fundamental problems of “Old IP.” In Myriad Genetics: In the Eye of the Policy Storm, they follow the story of Utah-based company, Myriad Genetics, and document mistakes the company made in protecting and enforcing patent rights on breast cancer genes in the United States and abroad.

“The mistakes in the Myriad case were not illegal actions, but political and strategic errors,” said McGill’s Gold. “In the United States this meant the company failed to reassure those conducting research on breast cancer that they would not be sued. Internationally, in nations with public health care systems, Myriad’s hardball tactics led to resistance from governments and in most places prevented Myriad from being able to license its diagnostic tests.”

Instead of securing international markets, he added, aggressive tactics undermined Myriad’s interests—not only for the breast cancer test, but for future products the company might want to market abroad.

And contrary to what industry says, according to the new research discussed today, the Myriad model of fiercely protecting patents is being replicated throughout the biotech and pharmaceutical industry. Cook-Deegan presented preliminary observations based on studies in progress about the behavior of a number of companies and institutions with patents on genes and diagnostic tests. He observed that companies are ignoring at their peril the lessons of Myriad and of the other examples cited in the International Expert Group’s report.

“Some of the same tactics that damaged Myriad’s reputation and harmed its business interests are being repeated by other companies, which are aggressively enforcing patents against university laboratory testing services,” Cook-Deegan said. “Such actions are affecting genetic testing for several diseases, including Alzheimer’s disease and Long QT syndrome, a condition that can make carriers extremely vulnerable to sudden cardiac death.”

Based on their research, Gold and Cook-Deegan conclude that such actions are decreasing the size of potential markets and alienating the payers that reimburse for testing, as well as the physicians who order tests and the consumers who seek them.

“In the end, the companies are undermining their long-term viability,” said Cook-Deegan. “Rather than treating their patents as clubs, the companies should use them as tools to foster collaboration with other companies, physicians, disease-group constituencies, reference laboratories, universities and academic researchers, as well as attending to the needs and expectations of purchasers of health care services both in the United States and around the world.”

‘Don’t Mess with Natural Allies’

Cook-Deegan notes that patents alone are not enough to guarantee the success of a patent holder. At least as important, he said, are the reimbursement policies of payers such as Medicare and Medicaid, the behavior of physician specialists who order genetic tests, collaborations with academic researchers and the support of advocacy groups.

“One lesson emerging from the case studies is that patents are important, but they are not enough to ensure financial success,” said Cook-Deegan. “Indeed, if patents tempt companies to overplay their hand, they can damage their own long term business interests. The warning to industry is, ‘Do not mess with your natural allies.'”

And patients, physicians, and payers are likely to push for access to the results of diagnostic tests, and greater and more flexible licensing of patents, Gold said. The report he and his team produced, drawing on the work of an extensive team of contributors, concludes that innovation occurs best when all parties – researchers, companies, NGOs, and governments – work collaboratively. They point to information technology as a model for how a new system might be designed.

“This doesn’t mean we don’t need a system for protecting intellectual knowledge,” Gold said. “But we need a system that is flexible enough to allow research to encourage innovation and benefit those who need it most.

“If companies adapt to the needs of consumers and payers through more open and flexible licensing, the biotechnology industry will thrive. Look at the way that change has swept through the world of information technology and brought benefits to millions, merely by engaging in broad and transparent licensing that results in a great deal of creativity and new products that address existing problems.”

Other recommendations from the International Expert Group report for national and international IP systems include:

Fostering greater trust between actors: A lack of trust has blocked collaborations to deliver lifesaving technologies, such as diagnostic tests, and has led to ineffective legislative reform. Independent trust builders who educate and encourage dialogue between industry, government, researchers and non-governmental organizations are essential.

Creating better ways to develop and deliver biotechnology products: This will require governments, researchers, industry and NGOs to collaborate through partnerships designed to:

encourage the sharing of molecular libraries and basic environmental technologies;

allow for exchanges of data, materials, and patents;

overcome concerns about high risk through joint public and private funding of promising avenues of research;

create patent pools to unblock the development, production and sale of medicines and technologies that the developing world needs to have a sustainable and secure economy.

Promoting more transparency and communication: Because the stakes are so high, the level of conversation about IP and science and technology policy must be raised and objectives and motives clearly stated.

Improving how data are collected and measured: Right now, the United States measures the wrong things about IP, particularly at public institutions and universities. The U.S. needs to figure out what it wants from innovation and how to measure it. New computer tools and digital information, much of it available on-line, will allow policy makers to explore a variety of factors in deciding how to proceed in patenting—or not—a piece of federally-funded research.

Public release date: 14-Oct-2008

Fructose Sets Table For Weight Gain Without Warning

Common sweetener found in many foods leads to leptin resistance and exacerbates obesity when paired with high-calorie, high-fat diet

BETHESDA, Md. (Oct. 16, 2008) – Eating too much fructose can induce leptin resistance, a condition that can easily lead to becoming overweight when combined with a high-fat, high-calorie diet, according to a new study with rats.

Although previous studies have shown that being leptin resistant can lead to rapid weight gain on a high-fat, high-calorie diet, this is the first study to show that leptin resistance can develop as a result of high fructose consumption. The study also showed for the first time that leptin resistance can develop silently, that is, with little indication that it is happening.

The study, “Fructose-induced leptin resistance exacerbates weight gain in response to subsequent high-fat feeding,” was carried out by Alexandra Shapiro, Wei Mu, Carlos Roncal, Kit-Yan Cheng, Richard J. Johnson and Philip J. Scarpace, all at the University of Florida College of Medicine in Gainesville. The study appears in the American Journal of Physiology – Regulatory, Integrative and Comparative Physiology, published by The American Physiological Society.

Leptin as regulator

Leptin is a hormone that plays a role in helping the body to balance food intake with energy expenditure. When leptin isn’t working — that is, when the body no longer responds to the leptin it produces — it’s called leptin resistance. Leptin resistance is associated with weight gain and obesity in the face of a high-fat, high-calorie diet.

Obesity has been a growing problem in the U.S. and in other parts of the world and fructose has been suspected of playing a role. Fructose is the sugar found in fruit, but it’s not the normal consumption of fruit that is the problem. Table sugar and high-fructose corn syrup are about 50% fructose and these ingredients have become increasingly common in many foods and beverages. With sugar and high-fructose corn syrup being added to many foods, people now eat much more fructose than ever before.

The University of Florida researchers hypothesized that a high-fructose diet could lead to leptin resistance, which in turn could lead to exacerbated weight gain in the face of a high-fat, high-calorie diet, a typical diet in industrialized countries. To test their hypothesis, the research team performed a study with two groups of rats. They fed both groups the same diet, with one important exception: one group consumed a lot of fructose while the other received no fructose.

Two groups similar over six months

During these six months, there were no differences in food intake, body weight, and body fat between rats on the high-fructose and the rats on the fructose-free diets. In addition, there was no difference between the two groups in the levels of leptin, glucose, cholesterol or insulin found in their blood. There was only one difference at the end of the six months: The rats on the high-fructose diet had higher levels of triglycerides in their blood.

The researchers next tested the animals to see if they were leptin resistant. They injected all the animals with leptin, to see if they would respond by eating less. Animals whose leptin response is functioning normally will lower their food intake. The researchers discovered that the rats on the high-fructose diet were leptin resistant, that is, they did not lower their food intake when given leptin. The no-fructose animals responded normally to leptin by eating less.

This first six months of the study showed that leptin resistance can develop silently. “Usually, leptin resistance is associated with obesity, but in this case, leptin resistance developed without obesity,” Shapiro said. “This was very surprising.”

Role of diet

Having seen that leptin resistance could develop silently, the researchers next wanted to find out what would happen if they switched the rats to a high-fat, high-calorie diet — the kind many Americans eat. They found that the animals exposed to the high-fructose diet, the leptin resistant rats, ate more and gained much more weight and fat than the leptin responsive animals on the fructose-free diet. All told, this study showed that leptin resistance can:

develop by eating a lot of fructose

develop silently, that is, with very little indication it is happening

result in weight gain when paired with a high fat, calorie dense diet

Scarpace said the study suggests it is the interaction between consumption of large amounts of fructose-containing foods and eating a high-fat, high-calorie diet that produces the weight gain. “This study may explain how the global increase in fructose consumption is related to the current obesity epidemic,” Shapiro said.

How it happens

Other studies have shown that elevated triglycerides impair the transport of leptin across the blood brain barrier. The researchers hypothesize that the elevation in triglycerides produced by fructose prevented leptin from reaching the brain. If leptin does not reach the brain, the brain will not send out the signal to stop eating.

“The presence of high fructose alters the way leptin works, fooling the brain so that it ignores leptin,” Scarpace said. Consumers should be cautious about what they eat, checking labels to see how much sugar the items contain, Shapiro said.

The researchers hope to perform future studies to find out if leptin resistance can be reversed by removing or reducing the fructose content of the diet.

Public release date: 20-Oct-2008

LEDs may help reduce skin wrinkles, researchers report.

Credit: American Chemical Society

Researchers in Germany are describing a potential alternative to Botox and cosmetic surgery for easing facial wrinkles. Their study, scheduled for the November 5 issue of ACS’ Crystal Growth & Design, a bi-monthly journal, reports that high intensity visible light from light emitting diodes (LEDs) applied daily for several weeks resulted in “rejuvenated skin, reduced wrinkle levels, juvenile complexion and lasting resilience.” LEDs are the miniature lights used in an array of products, from TV remote controls to traffic lights.

In the study, Andrei P. Sommer and Dan Zhu point out that high-intensity visible light has been used in medicine for more than 40 years to speed healing of wounds. That light actually penetrates into the skin, causing changes in the sub-surface tissue. Until now, however, scientists have not known the physicochemical nature of those changes.

They report identifying how the visible light works — by changing the molecular structure of a glue-like layer of water on elastin, the protein that provides elasticity in skin, blood vessels, heart and other body structures. Figuratively speaking, the light strips away those water molecules that are involved in the immobilization of elastin, gradually restoring its elastic function and thus reducing facial wrinkles. “We are justified in believing that our approach can be easily converted to deep body rejuvenation programs,” the researchers state. — AD

Public release date: 20-Oct-2008

10 Things the Food Industry Doesn’t Want You to Know

By Adam Voiland Adam Voiland

Two nutrition experts argue that you can’t take marketing campaigns at face value

With America’s obesity problem among kids reaching crisis proportions, even junk food makers have started to claim they want to steer children toward more healthful choices. In a study released earlier this year, the Centers for Disease Control and Prevention reported that about 32 percent of children were overweight but not obese, 16 percent were obese, and 11 percent were extremely obese. Food giant PepsiCo, for example, points out on its website that “we can play an important role in helping kids lead healthier lives by offering healthy product choices in schools.” The company highlights what it considers its healthier products within various food categories through a “Smart Spot” marketing campaign that features green symbols on packaging. PepsiCo’s inclusive criteria–explained here–award spots to foods of dubious nutritional value such as Diet Pepsi, Cap’n Crunch cereal, reduced-fat Doritos, and Cheetos, as well as to more nutritious products such as Quaker Oatmeal and Tropicana Orange Juice.

But are wellness initiatives like Smart Spot just marketing ploys? Such moves by the food industry may seem to be a step in the right direction, but ultimately makers of popular junk foods have an obligation to stockholders to encourage kids to eat more–not less–of the foods that fuel their profits, says David Ludwig, a pediatrician and the co-author of a commentary published in this week’s Journal of the American Medical Association that raises questions about whether big food companies can be trusted to help combat obesity. Ludwig and article co-author Marion Nestle, a professor of nutrition at New York University, both of whom have long histories of tracking the food industry, spoke with U.S. News and highlighted 10 things that junk food makers don’t want you to know about their products and how they promote them.

According to the Federal Trade Commission, food makers spend some $1.6 billion annually to reach children through the traditional media as well the Internet, in-store advertising, and sweepstakes. An article published in 2006 in the Journal of Public Health Policy puts the number as high as $10 billion annually. Promotions often use cartoon characters or free giveaways to entice kids into the junk food fold. PepsiCo has pledged that it will advertise only “Smart Spot” products to children under 12.

2. The studies that food producers support tend to minimize health concerns associated with their products.

In fact, according to a review led by Ludwig of hundreds of studies that looked at the health effects of milk, juice, and soda, the likelihood of conclusions favorable to the industry was several times higher among industry-sponsored research than studies that received no industry funding. “If a study is funded by the industry, it may be closer to advertising than science,” he says.

3. Junk food makers donate large sums of money to professional nutrition associations.

The American Dietetic Association, for example, accepts money from companies such as Coca-Cola, which get access to decision makers in the food and nutrition marketplace via ADA events and programs, as this release explains. As Nestle notes in her blog and discusses at length in her book Food Politics, the group even distributes nutritional fact sheets that are directly sponsored by specific industry groups. This one, for example, which is sponsored by an industry group that promotes lamb, rather unsurprisingly touts the nutritional benefits of lamb. The ADA’s reasoning: “These collaborations take place with the understanding that ADA does not support any program or message that does not correspond with ADA’s science-based healthful-eating messages and positions,” according to the group’s president, dietitian Martin Yadrick. “In fact, we think it’s important for us to be at the same table with food companies because of the positive influence that we can have on them.”

4. More processing means more profits, but typically makes the food less healthy.

Minimally processed foods such as fresh fruits and vegetables obviously aren’t where food companies look for profits. The big bucks stem from turning government-subsidized commodity crops–mainly corn, wheat, and soybeans–into fast foods, snack foods, and beverages. High-profit products derived from these commodity crops are generally high in calories and low in nutritional value.

5. Less-processed foods are generally more satiating than their highly processed counterparts.

Fresh apples have an abundance of fiber and nutrients that are lost when they are processed into applesauce. And the added sugar or other sweeteners increase the number of calories without necessarily making the applesauce any more filling. Apple juice, which is even more processed, has had almost all of the fiber and nutrients stripped out. This same stripping out of nutrients, says Ludwig, happens with highly refined white bread compared with stone-ground whole wheat bread.

6. Many supposedly healthy replacement foods are hardly healthier than the foods they replace.

In 2006, for example, major beverage makers agreed to remove sugary sodas from school vending machines. But the industry mounted an intense lobbying effort that persuaded lawmakers to allow sports drinks and vitamin waters that–despite their slightly healthier reputations–still can be packed with sugar and calories.

7. A health claim on the label doesn’t necessarily make a food healthy.

Health claims such as “zero trans fats” or “contains whole wheat” may create the false impression that a product is healthy when it’s not. While the claims may be true, a product is not going to benefit your kid’s health if it’s also loaded with salt and sugar or saturated fat, say, and lacks fiber or other nutrients. “These claims are calorie distracters,” adds Nestle. “They make people forget about the calories.” Dave DeCecco, a spokesperson for PepsiCo, counters that the intent of a labeling program such as Smart Spot is simply to help consumers pick a healthier choice within a category. “We’re not trying to tell people that a bag of Doritos is healthier than asparagus. But, if you’re buying chips, and you’re busy, and you don’t have a lot of time to read every part of the label, it’s an easy way to make a smarter choice,” he says.

8. Food industry pressure has made nutritional guidelines confusing.

As Nestle explained in Food Politics, the food industry has a history of preferring scientific jargon to straight talk. As far back as 1977, public health officials attempted to include the advice “reduce consumption of meat” in an important report called Dietary Goals for the United States. The report’s authors capitulated to intense pushback from the cattle industry and used this less-direct and more ambiguous advice: “Choose meats, poultry, and fish which will reduce saturated fat intake.” Overall, says Nestle, the government has a hard time suggesting that people eat less of anything.

Unless you follow politics closely, you wouldn’t necessarily realize that a group with a name like the Center for Consumer Freedom (CCF) has anything to do with the food industry. In fact,Ludwig and Nestle point out, this group lobbies aggressively against obesity-related public health campaigns–such as the one directed at removing junk food from schools–and is funded, according to the Center for Media and Democracy, primarily through donations from big food companies such as Coca-Cola, Cargill, Tyson Foods, and Wendy’s.

10. The food industry works aggressively to discredit its critics.

According to the new JAMA article, the Center for Consumer Freedom boasts that “[our strategy] is to shoot the messenger. We’ve got to attack [activists’] credibility as spokespersons.” Here’s the group’s entry on Marion Nestle.

The bottom line, says Nestle, is quite simple: Kids need to eat less, include more fruits and vegetables, and limit the junk food.

Public release date: 20-Oct-2008

Do cell phones increase brain cancer risk?

Philadelphia, 20 October 2008 – Major research initiatives are needed immediately to assess the possibility that using cellular phones may lead to an increased risk of brain tumors, according to an editorial in the November issue of the journal Surgical Neurology (http://www.surgicalneurology-online.com), published by Elsevier.

Recent studies have raised concerns that long-term exposure to electromagnetic fields (ELF) from cell-phone handsets can increase the risk of brain cancers and other nervous system tumors, according to the editorial by Dr. Ron Pawl, a neurosurgeon at Lake Forest Hospital, Lake Forest, Ill. He calls for collaborative research initiatives to determine whether the link between cell phones and brain cancer is real.

Scientists have long been concerned over the possibility that ELF exposure may increase the risk of brain cancers. Until recently, however, research has shown no clear link between cell phone use and brain tumors.

Earlier this year, a Swedish research group published an epidemiologic study suggesting an increased risk of brain cancers (gliomas) as well as acoustic nerve tumors (neuromas) in people using cell phones for ten years or longer. Tumors were more likely to develop on the same side as the cell phone was used. Other studies by the same group suggested that the use of wireless handsets in cordless home phones posed the same risk.

After reviewing the evidence, one author even suggested that long-term cell phone use is “more dangerous to health than smoking cigarettes.” Other recent commentators have raised similar concerns.

The findings are alarming in light of the exponential growth of cell phones—now including widespread use by children and teenagers. The damaging effects of ELF, if any, might be even greater in the developing brain.

If the link is real, then rates of brain cancers should have increased over the last two decades. Some studies have reported that this is the case, particularly for the most malignant brain cancers. However, other studies have found a stable tumor rate.

Some commentators have suggested that apparent increases in the number of brain cancers might reflect the use of sophisticated imaging techniques like computed tomography and magnetic resonance imaging. “However, the fact that the incidence of gliomas, especially the more malignant varieties, is increasing […] warrants action on this issue,” Dr. Pawl writes.

The problem, according to Dr. Pawl, is that no other research groups have performed actual studies showing a clear relationship between brain tumors and ELF. He calls on scientific societies to play a leading role in designing and conducting studies that will definitively determine the risks of brain cancer associated with ELF exposure, particularly from cell phones. “It seems that a cooperative effort by both the scientific community and state governing bodies will be needed,” writes Dr. Pawl. “Some spearhead is now necessary in view of the magnitude and seriousness of the situation.”

Public release date: 21-Oct-2008

US suicide rate increasing

Largest increase seen in middle-aged white women

The rate of suicide in the United States is increasing for the first time in a decade, according to a new report from the Johns Hopkins Bloomberg School of Public Health’s Center for Injury Research and Policy. The increase in the overall suicide rate between 1999 and 2005 was due primarily to an increase in suicides among whites aged 40-64, with white middle-aged women experiencing the largest annual increase. Whereas the overall suicide rate rose 0.7 percent during this time period, the rate among middle-aged white men rose 2.7 percent annually and 3.9 percent among middle-aged women. By contrast, suicide in blacks decreased significantly over the study’s time period, and remained stable among Asian and Native Americans. The results are published online at the website of the American Journal of Preventive Medicine and will be published in the December print edition of the journal.

The researchers also conducted a detailed analysis of suicide methods across specific population groups. While firearms remain the predominant method, the rate of firearm suicides decreased during the study period. Suicide by hanging or suffocation increased markedly with a 6.3 percent annual increase among men, and a 2.3 percent annual increase among women. Hanging/suffocation accounted for 22 percent of all suicides by 2005, surpassing poisoning at 18 percent.

“The results underscore a change in the epidemiology of suicide, with middle-aged whites emerging as a new high-risk group,” said study co-author Susan P. Baker, MPH, a professor with the Bloomberg School’s Center for Injury Research and Policy. “Historically, suicide prevention programs have focused on groups considered to be at highest risk—teens and young adults of both genders as well as elderly white men. This research tells us we need to refocus our resources to develop prevention programs for men and women in their middle years.”

Baker along with colleagues Guoqing Hu, PhD, Holly Wilcox, PhD, Lawrence Wissow, MD, MPH, analyzed data from the Web-based Injury Statistics Query and Reporting System (WISQARS) mortality reports, which provides data on deaths according to cause and intent of injury by age, race, gender and state. WISQARS mortality data are based on annual data files of the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC).

The reasons for the increase in the suicide rate are not fully understood. “While it would be straightforward to attribute the results to a rise in so-called mid-life crises, recent studies find that middle age is mostly a time of relative security and emotional wellbeing,” said Baker. “Further research is warranted to explore societal changes that may be disproportionably affecting the middle-aged in this country.”

Public release date: 21-Oct-2008

Splenda may damage gut bacteria, boost weight gain: study

By Stephen Daniells

25-Sep-2008 – Consumption of the sweetener Splenda at doses within the US FDA’s Acceptable Daily Intake may suppress beneficial bacteria in the gut, and cause weight gain, says a new rat study.

According to findings published in the peer-reviewed Journal of Toxicology and Environmental Health, Part A, a 12-week feeding study with the sweetener also affected the expression of certain enzymes known to interfere with the absorption of nutrients and pharmaceuticals.

The study, performed by researchers from Duke University in North Carolina and co-sponsored by the Sugar Association, may raise questions about the safety profile of the sweetener, reported to be used as an ingredient in over 4,000 products worldwide.

McNeil Nutritionals, the company behind Splenda, was quick to dismiss the study and draw attention to a number of other studies supporting the safety of the sweetener. The company questioned the methodology and the conclusions drawn by the researchers. Emphasis was also placed on the involvement of the Sugar Association as partial sponsor of the study.

Study methodology

The Duke University researchers separated 50 male Sprague-Dawley rats into five equal groups. One group was administered only water with its diet, thereby acting as the control group, while the other four groups had the diet supplemented with different doses of Splenda in water. The doses used were 100, 300, 500, and 1,000 mg of Splenda per kg of body weight per day, equivalent to sucralose doses of 1.1, 3.3, 5.5, and 11 mg per kg per day.

“These dosage levels were selected because they span the range of values below and above the accepted daily intake (ADI) for sucralose of 5 mg/kg/d established by the U.S. Food and Drug Administration (FDA),” wrote the researchers, led by Professor Mohammed Abou-Donia.

Moreover, Professor Abou-Donia told FoodNavigator.com that the study was performed with rats because they are the animal of choice for such studies. “The studies that were submitted for the approval of Splenda to the FDA were mostly performed in rats,” he said. “The Acceptable Daily Limit (ADI) approved by the FDA, was based on studies in rats.”

The study protocol was approved by the Duke University Institutional Animal Care and Use Committee (IACUC).

After 12 weeks, half of the animals in each group were sacrificed and the cytochrome P-450 (CYP) metabolism system and membrane efflux transporter P-glycoprotein (P-gp) were measured. Both P-gp and CYP are known to impact on the bioavailability of orally consumed compounds, such as drugs and nutrients.

The remaining animals spent a further 12 weeks without any Splenda in the diet.

Results

Professor Abou-Donia and his co-workers report that, at the end of the initial 12 weeks, significant reductions in the levels of so-called beneficial bacteria were observed. Specifically, the numbers of total anaerobes was decreased by 50 per cent, relative to the control animals, while bifidobacteria, lactobacilli, and Bacteroides were reduced by 37, 39, and 67.5 per cent respectively.

The body weight of the animals in all the groups increased, but significant increases were observed in animals receiving Splenda, said the researchers. Control animals experienced an increase in body weight of 93 per cent over the 12 weeks. Body weight increases in the 100, 300, 500, and 1,000 mg of Splenda per kg per day groups were 104, 101, 102, and 88.5 per cent, respectively.

“The lack of a dose-response effect of Splenda on body weight is likely due to the combined elevation of both intestinal P-gp and CYP that affected the bioavailability of Splenda,” stated the researchers. “At the higher concentrations, less Splenda was absorbed due to the increase in the expression of both P-gp and CYP proteins.”

Concerning P-gp and types of CYP, expression of P-gp increased by 2.43- fold, CYP3A4 by 2.51-fold, and CYP2D1 by 3.49-fold, over the course of the 12 weeks.

Low beneficial bacteria levels, and elevated P-gp and CYP levels were maintained after the 12 week recovery period, said the researchers.

“Evidence indicates that a 12 week administration of Splenda exerted numerous adverse effects, including a reduction in beneficial faecal microflora, an increased faecal pH, and enhanced expression levels of P-gp, CYP3A4, and CYP2D1, which are known to limit the bioavailability of orally administered drugs,” concluded the researchers.

Both industry and academia has responded to the results of the study. To read this reaction, click here.

How eating fruit and vegetables can improve cancer patients’ response to chemotherapy

RIVERSIDE, Calif. – The leading cause of death in all cancer patients continues to be the resistance of tumor cells to chemotherapy, a form of treatment in which chemicals are used to kill cells.

Now a study by UC Riverside biochemists that focuses on cancer cells reports that ingesting apigenin – a naturally occurring dietary agent found in vegetables and fruit – improves cancer cells’ response to chemotherapy.

Xuan Liu, a professor of biochemistry, and Xin Cai, a postdoctoral researcher working in her lab, found that apigenin localizes tumor suppressor p53, a protein, in the cell nucleus – a necessary step for killing the cell that results in some tumor cells responding to chemotherapy.

The study, published this week in the online early edition of the Proceedings of the National Academy of Sciences, provides a novel approach to conquer tumor resistance to chemotherapy, and suggests an avenue for developing safe chemotherapy via naturally occurring agents.

Normally, cells have low levels of p53 diffused in their cytoplasm and nucleus. When DNA in the nucleus is damaged, p53 moves to the nucleus where it activates genes that stop cell growth and cause cell death. In this way, p53 ensures that cells with damaged DNA are killed.

In many cancers, p53 is rendered inactive by a process called cytoplasmic sequestration. Apigenin is able to activate p53 and transport it into the nucleus, resulting in a stop to cell growth and cell death.

“In therapy you want to kill cancer cells,” explained Cai, the first author of the research paper. “But to stop cell growth and to kill the cell, p53 first needs to be moved to the cell’s nucleus to function. Apigenin is very effective in localizing p53 this way.”

Apigenin is mainly found in fruit (including apples, cherries, grapes), vegetables (including parsley, artichoke, basil, celery), nuts and plant-derived beverages (including tea and wine). It has been shown by researchers to have growth inhibitory properties in several cancer lines, including breast, colon, skin, thyroid and leukemia cells. It has also been shown to inhibit pancreatic cancer cell proliferation.

“Our study advocates the inclusion of vegetables and fruit in our daily diet to help prevent cancer,” said Liu, the research paper’s coauthor.

Public release date: 25-Oct-2008

Green tea may delay onset of type 1 diabetes

A powerful antioxidant in green tea may prevent or delay the onset of type 1 diabetes, Medical College of Georgia researchers say.

“Our study focused on Sjogren’s syndrome, so learning that EGCG also can prevent and delay insulin-dependent type 1 diabetes was a big surprise,” says Dr. Stephen Hsu, molecular/cell biologist in the School of Dentistry.

They found it also worked well in their original disease focus.

In the mouse, EGCG reduced the severity and delayed onset of salivary gland damage associated with Sjogren’s syndrome, which has no known cure.

“EGCG modulates several important genes, so it suppresses the abnormality at the molecular level in the salivary gland. It also significantly lowered the serum autoantibodies, reducing the severity of Sjogren’s syndrome-like symptoms,” Dr. Hsu says. Autoantibodies are antibodies the body makes against itself.

Both type 1 diabetes and Sjogren’s syndrome are autoimmune diseases, which cause the body to attack itself. Autoimmune disorders are the third most common group of diseases in the United States and affect about 8 percent of the population, says Dr. Hsu. Sjogren’s syndrome can occur alone or secondary to another autoimmune disease, such as lupus, rheumatoid arthritis or type 1 diabetes.

The study, published in the Oct. 24 issue of Life Sciences, supports earlier research showing EGCG’s impact on helping prevent autoimmune disease.

Researchers treated a control group of mice with water and a test group with a purified form of EGCG dissolved in the drinking water. At 16 weeks, the EGCG-fed mice were 6.1 times more likely to be diabetes-free than the water-fed group, and 4.2 times more likely at 22 weeks.

“Previous studies used another animal model that developed type 1 diabetes only after an injected chemical killed the insulin-producing cells. That may not accurately resemble disease development in humans, because type 1 diabetes is a genetic disease,” says Dr. Hsu, the study’s corresponding author.

“Our study is significant because we used a mouse model with the genetic defects that cause symptoms similar to human type 1 diabetes and Sjogren’s syndrome, so the immune cells attack the pancreas and salivary glands until they are no longer functional.”

Another related finding was that even when salivary cells were under attack, they seemed to be rapidly reproducing in the control group. The proliferation was suppressed in the EGCG-fed group.

“It’s kind of counterintuitive – why would there be proliferation of the glandular cells occurring when the present cells are not secreting saliva?” says Dr. Kevin Gillespie, first author of the study he conducted for his master’s research project at MCG.

The proliferation phenomenon also can be observed in psoriasis, an autoimmune disease affecting the skin and joints, says Dr. Hsu. “Normal skin cells turn over every 30 days or so, but skin cells with psoriasis turn over every two or three days.” Dr. Hsu’s group previously found that green tea polyphenols, including EGCG, inhibited rapid proliferation in an animal model for human psoriasis.

“We never thought proliferation was going on to this extent in the salivary gland, but we now believe it is tightly associated with Sjogren’s syndrome,” he says.

The next step is to observe Sjogren’s syndrome in human salivary gland samples to determine whether the study findings hold up in humans.

“If the abnormal expression of these genes is the same in humans as in the animal model, then the second stage will be intervention and treatment with a pure form of EGCG,” says Dr. Hsu.

“The benefit of using green tea in preventing or slowing these autoimmune diseases is that it’s natural and not known to harm the body,” says Dr. Gillespie, periodontics chief resident at Fort Gordon’s Tingay Dental Clinic. “EGCG doesn’t have the negative side-effects that can be associated with steroids or other medications that could otherwise be prescribed.”

Public release date: 25-Oct-2008

Rheumatoid arthritis rising among women

ROCHESTER, Minn. — After four decades on the decline, rheumatoid arthritis is on the upswing among women in the United States. That’s the finding presented by Mayo Clinic investigators at the annual meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals in San Francisco.

“This is a significant finding and an indicator that more research needs to be done to better understand the causes and treatment of this devastating disease,” says Sherine Gabriel, M.D., Mayo Clinic rheumatologist and lead investigator on the study.

From 1955 to 1994, the incidence of rheumatoid arthritis had continually been on the decline. That apparently changed beginning in the mid-1990s. When Mayo researchers analyzed patient data from early 1995 to the start of 2005, they found that both the incidence and prevalence (percentage) of the condition were rising.

Compared to the previous decade when approximately 36 women out of every 100,000 developed rheumatoid arthritis each year, the new study showed a jump to 54 women in the more recent decade. The incidence for men remained at about 29 per 100,000. Overall, the percentage of the entire population with the condition rose from 0.85 percent to 0.95 percent.

Researchers say it’s not clear why this is happening, but an environmental factor may have a role in the shifting incidence and prevalence among women.

The study included 350 adult patients from Olmsted County, MN, whose average age was 56.5 years. The majority, 69 percent, were women.

Public release date: 25-Oct-2008

OSTEOPOROSIS DRUGS INCREASE RISK FOR HEART PROBLEMS

(Philadelphia, PA, October 27, 2008) — People who take bisphosphonates for osteoporosis

may be at risk for serious atrial fibrillation (AF), or irregular heartbeats, according to a new study.

The research, presented at CHEST 2008, the 74th annual international scientific assembly of the

American College of Chest Physicians (ACCP), shows that people taking alendronate or zoledronic acid, two common medications to prevent or slow the occurrence of osteoporosis, were significantly more likely to experience serious AF, including hospitalization or death, compared with placebo.

“Atrial fibrillation can be serious if it is persistent or occurs in people with preexisting heart

left untreated, it can lead to pulmonary edema, congestive heart failure, or the formation of a blood

clot that can cause a brain embolism and stroke.”

In a metaanalysis, Dr. Miranda and colleagues from the University of Miami evaluated the

relationship between the use of bisphosphonates and AF, a condition that can produce a wide range

of symptoms, including light-headedness, palpitations, chest pain, and shortness of breath, or no

symptoms at all.

Three studies met eligibility criteria and included a total of 16,322 patients, of whom 76 to 100 percent were women using bisphosphonates for osteoporosis with a mean age range 69 to 75 years. Patients in the study were taking alendronate or zoledronic acid. The analysis showed that 2.5 to 3 percent of patients taking bisphosphonates experienced atrial fibrillation and 1 to 2 percent experienced serious AF, including hospitalization or death. Patients taking bisphosphonates were more likely to experience AF than patients receiving placebo and up to two times more likely to experience serious AF than patients receiving placebo.

“In patients with increased risk factors for atrial fibrillation, clinicians should be more

cautious when choosing treatment for osteoporosis and weigh the risks against the benefit of

decreased fracture risk,” said Dr. Miranda.

“Bisphosphonates are widely used to treat millions of women and men who suffer from

osteoporosis or low bone density,” said James A. L. Mathers, Jr., MD, FCCP, President of the

American College of Chest Physicians. “A potential link between bisphosphonates and atrial

fibrillation warrants additional research in this area.”

Public release date: 27-Oct-2008

How drug companies covertly promote off-label drug use

Off-label prescription of a drug is generally legal, but promotion of off-label uses by a drug manufacturer is illegal. In an article in this week’s PLoS Medicine, two physician researchers describe the techniques that drug companies use to covertly promote off-label use, even when such promotion is illegal.

Adriane Fugh-Berman (Georgetown University Medical Center, Washington DC) and Douglas Melnick (a preventive medicine physician working in North Hollywood, California) argue that while off-label drug use is “sometimes unavoidable” and sometimes “demonstrably beneficial,” it has also been linked with serious side effects. Off-label drug use, they say, “should be undertaken with care and caution due to the uncontrolled experiment to which a patient is being subjected”.

Nevertheless, drug companies have a stake in promoting such off-label use, say the authors, since increased off-label use means “larger revenues from larger user populations, especially for products with narrow indications”.

Based on Dr Melnick’s previous experience working in the pharmaceutical industry in medical affairs (supporting drug marketing) and both authors’ current contacts within the industry, they outline some of the ways that drug companies can promote such off-label use.

One example is known as the “decoy indication”.

In development, say the authors, drugs may be promising for several uses, and companies must choose one or two conditions on which to focus research. Ease of approval is the most important factor in this decision. If extensive off-label use is anticipated, a company may seek approval for just a narrow indication in order to speed a drug to market. In other words, a drug may be approved for this very narrow “decoy indication” while an extensive off-label campaign is not disclosed to drug regulators.

Another technique is to use drug representatives, even though in the US drug reps are not supposed to detail doctors on off-label uses. The authors quote an article in Medical Marketing and Media in which a pharmaceutical industry attorney says: “Before engaging in off-label promotion, companies should ascertain the risk profile, safety, efficacy, and potential commercial benefits of the use—without committing that last bit to print”. In other words, say Fugh-Berman and Melnick, illegal promotion may be cost-effective if potential profits trump potential fines.

Pharmaceutical marketing, they say, has “distorted the discourse on off-label uses and encouraged the unmonitored, potentially dangerous use of drugs by patients for whom risks and benefits are unknown.”

“Companies that engage in off-label promotion should be heavily fined and their future marketing practices subject to increased scrutiny by regulatory agencies.”

Public release date: 27-Oct-2008

How toxic environmental chemical DBT affects the immune system

An international team of researchers at the University of California, San Diego School of Medicine and the University of Basel in Switzerland have issued a report on the mechanism of toxicity of a chemical compound called Dibutyltin (DBT). Their findings will be published by PLoS ONE on October 28.

DBT is part of a class of high toxic and widely distributed chemical compounds called organotins, DBT is most commonly used as an anti-fouling agent in paint, for example in the fishing and shipbuilding industries. It is also used in the production of polyvinyl chloride (PVC) plastic tubes and bottles.

According to co-lead investigators Michael E. Baker, Ph.D., researcher in UC San Diego’s Department of Medicine, Division of Nephrology-Hypertension, and Alex Odermatt, Ph.D., at the University of Basel, DBT is closely related to tributyltin (TBT), another well-known pollutant. Concern about the side effects of TBT led the United Nations’ International Maritime Organization to organize a global ban on its use.

“TBT is metabolized by the body’s liver into DBT,” the scientists explained. “Humans are also exposed to DBT by drinking water from PVC pipes. Because it is poorly broken down, DBT remains in the environment and it appears that its toxic effects are more rapid and more pronounced than those of TBT.”

Symptoms of organotin exposure can include irritated skin, dizziness, difficulty breathing, and flu-like symptoms. Although long-terms effects in humans are uncertain, large doses of certain organotins have been shown to damage the reproductive and central nervous systems, bone structure, the liver and immune system in mammals.

Combining studies of the effect in cell culture of DBT on the function of a key class of steroid hormone, glucocorticoids, with computer-based analyses of the molecular interaction of DBT and the glucocorticoid receptor (GR), the U.S. and Swiss scientists explained the mechanism by which DBT inhibits transcriptional activity of the GR.

The GR is expressed in almost every cell in the body. Besides important functions in energy metabolism, the GR helps to regulate genes that control the body’s immune system. The researchers propose that by blocking GR activation, DBT disrupts the appropriate response of the immune system during inflammation, providing an explanation for some of the toxic effects of this organotin.

Public release date: 27-Oct-2008

ANTISEIZURE DRUG COULD BE FATAL

(Philadelphia, PA, October 28, 2008) – Patients treated for their prolonged seizures with

the sedative propofol may be at high risk for complications and even death. New research presented at CHEST 2008, the 74th annual international scientific assembly of the American College of Chest Physicians (ACCP), shows that the use of propofol as an antiepileptic agent in patients with refractory status epilepticus (RSE), prolonged seizures that do not respond to initial treatment, was associated with significant mortality and morbidity. RSE is a difficult clinical problem seen in patients with primary epilepsy and in those with other conditions such as trauma, tumors, and infections affecting the brain. Although propofol isused to treat patients with RSE, it is more commonly used for sedation during surgeries or other patient procedures but at a much lower dose and shorter duration than that used for the control of seizures.

“Patients with RSE treated with propofol are at high risk for propofol-related side effects

because of the high propofol infusion rates and prolonged treatment duration necessary in these patients,” said Vivek Iyer, MD, Mayo Clinic, Rochester, MN. “However, it is well described that propofol toxicity can occur even with brief exposure to the drug.”

Dr. Iyer and his colleagues from Mayo Clinic reviewed 39 consecutive patients (median age of 54 years) from 1997 to 2007, who were admitted to the ICU with RSE, in order to examine the link between propofol use and related side effects, including propofol infusion syndrome (PRIS). PRIS is a usually fatal complication of propofol use that has been reported especially at high infusion rates for prolonged periods. For this study, PRIS was defined by the unexplained presence of at least one or more of the following: metabolic acidosis, rhabdomyolysis, bradycardia, and/orcardiac arrest Propofol was used in 32 (82 percent) of the patients (group A) for a median of 63 hours and a median peak infusion rate of 67 mcg/kg/min. Other agents, such as midazolam and pentobarbital,

were used in the other seven (18 percent) patients (group B). Within group A, three patients had sudden unexplained cardiac arrest while on propofol infusions, resulting in two deaths, while no deaths occurred in group B. Median hospital stay (12 days) and ICU length of stay (9 days) did not differ between the two groups. The overall occurrence of PRIS was 30 percent of patients in group A (seven patients with bradycardia, three patients with sudden unexplained cardiac arrest) compared with less than 3 percent (one patient with bradycardia) in group B.

In light of the new data, Dr. Iyer advises that caution should be taken with the use of

propofol to treat patients with RSE. “There are several other medications we can turn to in the case of uncontrolled seizures,” he said. “Alternative agents should first be tried for patients with RSE, and propofol should only be used after exhausting all other options.”

Public release date: 27-Oct-2008

OMEGA-3 FATTY ACID LEVELS MAY AFFECT SLEEP APNEA SEVERITY

The level of omega-3 fatty acids found in a patient’s blood may determine the severity of his or her sleep apnea. Researchers from the University of Missouri, Kansas City, MO, tested fatty acid levels in 350 subjects with apnea-hypopnea index scores of 0 to 104. Results showed that lower levels of docosahexaenoic acid (DHA), a type of omega-3 fatty acid, was associated with increased apnea severity, even after controlling for age, sex, race, smoking, BMI, fish intake, omega-3 supplementation, flaxseed oil supplementation, and other fatty acids normally present in cellular membranes. Researchers are unclear whether the increased severe apnea induces systemic changes, which lower DHA levels, or whether lower DHA levels might lead to worsening apnea.

Public release date: 28-Oct-2008

Methylmercury warning

Recent studies hint that exposure to the toxic chemicals, such as methylmercury can cause harm at levels previously considered safe. A new analysis of the epidemiological evidence in the International Journal of Environment and Health, suggests that we should take a precautionary approach to this and similar compounds to protect unborn children from irreversible brain damage.

Philippe Grandjean of the Department of Environmental Health at Harvard School of Public Health, in Boston, and the University of Southern Denmark in Odense, explains that the causes of suboptimal and abnormal mental development are mostly unknown. However, severe exposure to pollutants during the development of the growing fetus can cause problems that become apparent as brain functions develop – and ultimately decline – in later life. Critically, much smaller doses of chemicals, such as the neurotoxic compound methylmercury, can harm the developing brain to a much greater extent than the adult brain.

Methylmercury is a chemical compound formed in the environment from released mercury. Unfortunately, the methylmercury can be transported quickly around the body and may enter the brain. Serious problems will ensue if important developmental processes are blocked as there will be only one chance for the brain to develop.

The researchers point out that until recently research into the effects of pollutants on the brain has been clouded by the lack of information on actual exposure. Moreover, finding a direct link between specific problems with the brain and exposure relies on statistical, or epidemiological, analysis rather than case-by-case understanding. The researchers say that neurodevelopmental disorders of possible environmental origin affect between 5% and 10% of babies born worldwide, leading to dyslexia, mental retardation, attention deficit/hyperactivity disorder, cerebral palsy, and autism.

The toxicity of methylmercury is well known, but the researchers believe that the medical world has underestimated the risk of brain damage associated with exposure to this compound as well as numerous others. Professor Grandjean emphasizes that little research has been carried out into the effects of other neurotoxic chemicals.

“Until there is enough evidence to rule out effects of certain chemicals on the developing nervous system, a cautious approach would involve strict regulation of suspected developmental neurotoxicants and prudent counseling of expectant mothers regarding exposures to untested substances,” the researchers conclude.

Philadelphia, PA, October 28, 2008 – A growing body of research data suggests that consuming foods rich in polyphenols from grapes, including red wine, helps reduce the risk of heart disease, according to a review article in the November issue of Nutrition Research.

“Consumption of grape and grape extracts and/or grape products such as red wine may be beneficial in preventing the development of chronic degenerative diseases such as cardiovascular disease,” write Wayne R. Leifert, Ph.D., and Mahinda Y. Abeywardena, Ph.D., of Commonwealth Scientific and Industrial Research Organisation in Adelaide, Australia.

The authors review the accumulating evidence that grape polyphenols work in many different ways to prevent cardiovascular and other “inflammatory-mediated” diseases. Polyphenols are natural antioxidants found in grapes and some other plant foods. Their types and actions vary, depending on where in the grape they are found. Grape seeds, grape skin, and grape juice contain several types of polyphenols, including resveratrol, phenolic acids, anthocyanins, and flavonoids.

Through their antioxidant effects, grape polyphenols help to slow or prevent cell damage caused by oxidation. Polyphenols decrease oxidation of low-density lipoprotein cholesterol (“bad” cholesterol)—a key step in the development of atherosclerosis (hardening of the arteries). Grape polyphenols also have other protective effects on the heart and blood vessels, including actions to reduce blood clotting, abnormal heart rhythms, and blood vessel narrowing. It’s not yet clear exactly how these benefits of polyphenols occur, although there is evidence of effects on cellular signaling and on the actions of certain genes. The wide range of health-promoting effects suggests that several different, possibly interrelated mechanisms may be involved.

So far, most of the evidence on grape polyphenols comes from laboratory experiments and animal studies. However, a few studies support the disease-preventing benefits of grapes in humans. Studies in patients treated with grape seed extracts have shown improvements in blood flow and cholesterol levels. In other studies, drinking Concord grape juice has improved measures of blood flow in patients with coronary artery disease and lowered blood pressure in patients with hypertension.

Studies investigating the lower rates of heart disease in France—the so-called “French paradox”—first raised the possibility that red wine might have health benefits. The subsequent research reviewed by Drs. Leifert and Abeywardena helps build the case that grapes and grape products might be a useful part of strategies to lower the high rate of death from cardiovascular disease.

At a time of growing interest in the use of “functional foods and nutraceuticals” to promote heart health, grapes and grape polyphenols are “attractive candidates” for use in such supplements, Drs. Leifert and Abeywardena believe. “Therefore,” they conclude, “supplementation with grape seed, grape skin or red wine products may be a useful adjunct to consider for a dietary approach in the prevention of cardiovascular diseases, although additional research is required to support such a strategy.”

Public release date: 28-Oct-2008

What the election means to the nutrition industry?

The Natural Products Association (NPA) is often asked by members and others, “What effect will the upcoming elections have on the natural-products industry?” More to the point, “What will happen to regulation of dietary supplements under a new administration — whether Democratic or Republican?”

Unfortunately, there is not a simple or definitive answer based on a victory by either Sen. John McCain or Sen. Barack Obama. But let me first preface my remarks by saying that the NPA does not — and cannot — endorse either candidate. A constellation of factors and issues affects an individual’s vote, and the potential impact on his or her livelihood is typically among them. What I’m attempting here is to shed some light on past legislative behaviors that might — and the key word here is “might” — impact future public-policy issues. So let’s take a look.

While both candidates have been in the U.S. Senate and voted on a variety of legislation, there really hasn’t been an up or down vote on a bill that was as pivotal to the industry as the passage of the Dietary Supplement Health and Education Act in 1994. And while the DSHEA passed in the Senate, it was by “unanimous consent” and did not require a roll-call vote. That means that no senator actually cast an individual vote, including McCain, who was in office at the time. That’s why it’s hard to speculate how either of the candidates might vote on a bill that will affect the industry’s future.

Since the DSHEA passed, there have been bills introduced that would affect both positively and negatively, the way dietary supplements are regulated. We’ve seen some of the same co-sponsors on bills we both supported and opposed. For instance, McCain was a co-sponsor with Sen. Durbin of a bill that would have required pre-market approval for dietary supplements, something the industry has vehemently opposed. But McCain has also co-sponsored legislation supported by the industry, such as the anabolic steroid and adverse-event bills. And while McCain has been critical of the regulation of dietary supplements in regard to performance-enhancing products, he hasn’t made the kind of sweeping statements regarding increasing regulation that legislators such as Sen. Richard Durbin or Rep. Henry Waxman have. During his two years in Congress, Obama has not expressed a position on the issues affecting our industry.

Both McCain and Obama presented platforms that call for total health care reform and changes.

Durbin, like Obama, is from Illinois, and as the senior senator from Illinois, Obama’s seatmate and friend, and the current No 2 in Senate leadership, is very likely to have his opinions heard in a Democratic administration. Bear in mind, two critical appointments will be the Secretary of Health and Human Services, who will oversee the Food and Drug Administration, and the FDA’s new commissioner, thus the regulation of dietary supplements.

Regarding the senate as a whole, if the predictions are correct, there could be a super-majority of Democrats that would make legislation introduced there essentially filibuster-proof. What that means is that bills we oppose might be harder to stop by our champions. Since, in the Senate, amendments can be introduced at any time on the floor we’ve got to remain even more vigilant in monitoring what is happening there.

Conventional wisdom says that Republicans favor less regulation. However, we need to remember that the DSHEA was passed with a Democratic administration. And, the industry has enjoyed fairly broad bipartisan support.

But whatever happens regarding a new administration and changes in Congress, there is much that we as an industry can do to help ensure that dietary supplements continue to enjoy regulation that balances consumer protection with market access.

This includes taking advantage of opportunities offered by the NPA, such as our annual lobbying event, and other groups, to communicate with your legislators the positive impact dietary supplements have for all Americans. Whether through an e-mail message or an in-person meeting in your district, or on Capitol Hill, as a constituent you have tremendous power to influence the outcome of public-policy decisions. We’ll continue to do our part to make advocacy easy and effective, but your participation is vital.

Please take a moment to view the above presentation, excerpted from one I recently presented to attendees at Expo East 2008. I think it will give you a better idea of how important your participation is for this election and in this coming year.

-David R Seckman, executive director and CEO

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These reports are done with the appreciation of all the Doctors, Scientist, and other Medical Researchers who sacrificed their time and effort. In order to give people the ability to empower themselves. Without the base aspirations for fame, or fortune. Just honorable people, doing honorable things.